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Oncology Newsfeed

  • ACCC to Host 12/5 Webinar on Part B Proposed Changes

    On Thursday, October 25, the Trump Administration released of a three-pronged proposal to overhaul Medicare Part B and tackle rising drug costs. ACCC looks forward to commenting on this proposal, but the Administration's actions are still in the nascent stages of development. An Advance Notice of Proposed Rulemaking (ANPRM) was released on October 25, with expectation that a formal proposed rule would be released in Spring 2019. Many questions are yet to be addressed regarding the intricacies in implementation of this model.

    Under the proposal the Medicare Part B landscape would change significantly through the use of a mandatory demonstration through the Center for Medicare and Medicaid Innovation (CMMI) with an International Pricing Index (IPI) model. ACCC has expressed overarching concerns about the impact of the proposal on the entire cancer care delivery infrastructure and, in particular, those programs and practices that see a high percentage of Medicare, Medicare only, and dual-eligible patients.

    As ACCC urges policymakers to be aware the effect this demonstration has on the oncology community, we invite you to hear from ACCC and our legal experts at Hogan Lovells to learn more about this proposed mode and what it could mean for your cancer program and your patients.

    Webinar: Health Policy to Watch: Medicare Part B Drug Pricing Reform - The International Pricing Index (IPI) Model
    Wednesday, December 5, 2018
    3:30 PM - 4:30 PM EST
    Register here (login required).

    Posted 11/29/2018



  • FDA Approves First Biosimilar to Rituxan

    On November 28, the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

    Read the full FDA press release here.

    Posted 11/28/2018


  • FDA Approves Gilteritinib for Acute Myeloid Leukemia

    On November 28, the Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma US Inc.) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

    The FDA also approved an expanded indication for a companion diagnostic, to include use with gilteritinib. The LeukoStrat CDx FLT3 Mutation Assay, (Invivoscribe Technologies, Inc.) is used to detect the FLT3 mutation in patients with AML.

    Read the full FDA press release here.

    Posted 11/28/2018



  • FDA Approves Larotrectinib for Solid Tumors with NTRK Gene Fusion

    On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

    Read the full FDA press release here.

    Posted 11/27/2018


  • CMS Releases Medicare Part C and Part D Proposed Rule

    On November 26, the Centers for Medicare & Medicaid Services (CMS) announced proposed policies that continue to tackle drug pricing reform. Top-line takeaways from today’s proposals include:

    • Proposed reform to Medicare Part D’s “protected” therapeutic classes.
    • A new requirement in Medicare Part D to allow for increased transparency between patient and provider with provision of out-of-pocket cost obligations for prescription drugs whenever a prescription is written.
    • A continued push to allow for and implement “step therapy” in Medicare Advantage plans for Part B drugs. The proposed rule also states the potential to infuse prior authorizations within this pool as well.
    • Proposed implementation of a “statutory requirement” that would prohibit pharmacy gag clauses in Part D.

    Read the CMS fact sheet on the proposed rule here.
    Read the full proposed rule here.

    The ACCC policy team is continuing to analyze this proposal. Stay tuned for more updates.

    Posted 11/26/2018


  • ACCC Signs Letter of Support for CLINICAL TREATMENT Act

    On November 26, the Association of Community Cancer Centers (ACCC) joined dozens of cancer care organizations and associations in signing a letter of support for H.R. 6836, the CLINICAL TREATMENT Act. This legislation would ensure that states cover routine care costs of participation in approved clinical trials for Medicaid enrollees with life-threatening conditions. Medicaid is currently the only major payer that is not required by federal law to cover these costs.

    Read the full letter of support for H.R. 6836 here.

    Posted 11/26/2018


  • FDA Approves Venetoclax for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/18



  • FDA Approves Glasdegib for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/2018


  • ACS Releases Report on Current State of Cancer Screening

    On November 19, the American Cancer Society (ACS) published a report in CA: A Cancer Journal for Clinicians discussing the status of cancer screening and proposing key areas where further attention is needed. ACS highlighted five key focus areas to help cancer screening realize its full potential:
    • Improving the implementation of existing screening modalities
    • Improving the quality and performance of currently available screening tests
    • Developing entirely new screening strategies to screen for cancers currently amenable to screening
    • Developing increasingly refined, risk-based screening strategies
    • Developing effective ways to screen for cancers for which screening tests do not exist.
    Read the full report here.

    Read the ACS press release on the report here.

    Posted 11/19/2018


  • "Feel More Like You" Program to Help Cancer Patients with Physical Changes

    On November 19, Walgreens announced the launch of its "Feel More Like You" program designed to assist people living with cancer manage the physical changes associated with treatment. Formed in collaboration with Look Good, Feel Better and Cancer Support Community, the program will feature trained beauty consultants and pharmacists working together to provide personalized support to individuals with cancers at more than 400 stores across the country.

    Read the full Walgreens press release here.

    Posted 11/19/18